FDA product code QHW: Single Lumen Ecmo Cannula
QHW is the FDA product code for single lumen ecmo cannula. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under QHW, 3 in the last five years. The average 510(k) review took 301 days (median 216); 134 days on average over the last three years.
Definition
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Classification
| Field | Value |
|---|---|
| Device name | Single Lumen Ecmo Cannula |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 633 |
| 2024 | 1 | 53 |
| 2026 | 1 | 216 |
Compare with all 510(k) review times · Search every QHW clearance
Top QHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 3 | 2026-01-15 |
Most recent QHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251831 | Medtronic, Inc. | Bio-Medicus Life Support Catheter and Introducer | 2026-01-15 | 216 |
| K240534 | Medtronic, Inc. | Bio-Medicus Life Support Catheter and Introducer | 2024-04-19 | 53 |
| K201057 | Medtronic, Inc. | Bio-Medicus Life Support Catheter and Introducer | 2022-01-14 | 633 |
Recalls for QHW devices
openFDA lists no recalls for product code QHW.
Frequently asked questions
What is FDA product code QHW?
QHW is the FDA product code for single lumen ecmo cannula. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is QHW?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHW?
Across 3 cleared submissions the average was 301 days from receipt to decision (median 216).
Which companies have the most QHW clearances?
Medtronic, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QHW
- Run a recall and safety report across every QHW manufacturer
- Watch product code QHW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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